Median Lobe Destruction Apparatus and Method

ABSTRACT

A system and associated method for altering or destroying tissues and anatomical or other structures in medical applications for the purpose of treating diseases or disorders. In one aspect, the system includes a device configured to deploy devices for altering the lobes of a prostate.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a continuation-in-part of: 1) copending U.S. patentapplication Ser. No. 12/852,243, filed Aug. 6, 2010; 2) copending U.S.patent application Ser. No. 12/512,674, filed Jul. 30, 2009 which claimsthe benefit of Provisional Application Ser. No. 61/084,937; 3) copendingU.S. patent application Ser. No. 11/775,162, filed Jul. 9, 2007: 4)copending U.S. patent application Ser. No. 11/671,914, filed Feb. 6,2007; 5) copending U.S. patent application Ser. No. 11/492,690, filed onJul. 24, 2006; 6) copending U.S. patent application Ser. No. 11/833,660,filed on Aug. 3, 2007, which is a continuation of U.S. patentapplication Ser. No. 11/318,246, filed on Dec. 20, 2005; and 7)copending U.S. patent application Ser. No. 11/838,036 filed on Aug. 13,2007, which is a continuation of U.S. patent application Ser. No.11/134,870 filed on May 20, 2005; the entire disclosures of each ofwhich are expressly incorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates generally to medical devices and methods,and more particularly to systems and associated methods for altering ordestructing tissues and anatomical or other structures within the bodyof human or animal subjects for the purpose of treating diseases ordisorders.

One example of a condition where it is desirable to lift, compress orotherwise remove a pathologically enlarged tissue is Benign ProstaticHyperplasia (BPH). BPH is one of the most common medical conditions thataffect men, especially elderly men. It has been reported that, in theUnited States, more than half of all men have histopathologic evidenceof BPH by age 60 and, by age 85, approximately 9 out of 10 men sufferfrom the condition. Moreover, the incidence and prevalence of BPH areexpected to increase as the average age of the population in developedcountries increases.

The prostate gland enlarges throughout a man's life. In some men, theprostatic capsule around the prostate gland may prevent the prostategland from enlarging further. This causes the inner region of theprostate gland to squeeze the urethra. This pressure on the urethraincreases resistance to urine flow through the region of the urethraenclosed by the prostate. Thus the urinary bladder has to exert morepressure to force urine through the increased resistance of the urethra.Chronic over-exertion causes the muscular walls of the urinary bladderto remodel and become stiffer. This combination of increased urethralresistance to urine flow and stiffness and hypertrophy of urinarybladder walls leads to a variety of lower urinary tract symptoms (LUTS)that may severely reduce the patient's quality of life. These symptomsinclude weak or intermittent urine flow while urinating, straining whenurinating, hesitation before urine flow starts, feeling that the bladderhas not emptied completely even after urination, dribbling at the end ofurination or leakage afterward, increased frequency of urinationparticularly at night, urgent need to urinate etc.

In addition to patients with BPH, LUTS may also be present in patientswith prostate cancer, prostate infections, and chronic use of certainmedications (e.g. ephedrine, pseudoephedrine, phenylpropanolamine,antihistamines such as diphenhydramine, chlorpheniramine etc.) thatcause urinary retention especially in men with prostate enlargement.

Although BPH is rarely life threatening, it can lead to numerousclinical conditions including urinary retention, renal insufficiency,recurrent urinary tract infection, incontinence, hematuria, and bladderstones.

In developed countries, a large percentage of the patient populationundergoes treatment for BPH symptoms. It has been estimated that by theage of 80 years, approximately 25% of the male population of the UnitedStates will have undergone some form of BPH treatment. At present, theavailable treatment options for BPH include watchful waiting,medications (phytotherapy and prescription medications), surgery andminimally invasive procedures.

For patients who choose the watchful waiting option, no immediatetreatment is provided to the patient, but the patient undergoes regularexams to monitor progression of the disease. This is usually done onpatients that have minimal symptoms that are not especially bothersome.

Surgical procedures for treating BPH symptoms include TransurethalResection of Prostate (TURP), Transurethral Electrovaporization ofProstate (TVP), Transurethral Incision of the Prostate (TUIP), LaserProstatectomy and Open Prostatectomy.

Minimally invasive procedures for treating BPH symptoms includeTransurethral Microwave Thermotherapy (TUMT), Transurethral NeedleAblation (TUNA), Interstitial Laser Coagulation (ILC), and ProstaticStents.

The most effective current methods of treating BPH carry a high risk ofadverse effects. These methods and devices either require general orspinal anesthesia or have potential adverse effects that dictate thatthe procedures be performed in a surgical operating room, followed by ahospital stay for the patient. The methods of treating BPH that carry alower risk of adverse effects are also associated with a lower reductionin the symptom score. While several of these procedures can be conductedwith local analgesia in an office setting, the patient does notexperience immediate relief and in fact often experiences worse symptomsfor weeks after the procedure until the body begins to heal.Additionally all device approaches require a urethral catheter placed inthe bladder, in some cases for weeks. In some cases catheterization isindicated because the therapy actually causes obstruction during aperiod of time post operatively, and in other cases it is indicatedbecause of post-operative bleeding and potentially occlusive clotformation. While drug therapies are easy to administer, the results aresuboptimal, take significant time to take effect, and often entailundesired side effects.

There have been advances in developing minimally invasive devices andmethods for lifting and repositioning of tissues. For example,approaches have been proposed to displace and/or compress lobes of aprostate gland to receive pressure on and provide a less obstructed paththrough a urethra.

There remains, however, a need for the development of new devices andmethods that can be used for various procedures where it is desired toalter or destruct the lobes of a prostate in a minimally invasivemanner. In particular, there is a need for alternative apparatus andtreatment approaches for the purpose of treating median lobes of aprostate. Various structures ensuring an effective interventionalprocedure have been found to be needed.

The present disclosure addresses these and other needs.

SUMMARY

Briefly and in general terms, the present invention is directed towardsan apparatus and method for treating the prostate. In one particularembodiment, structure is provided to accomplish desired destruction oralteration of a lobe of a prostate. A treatment device is provided toaccess the anatomy targeted for the interventional procedure, such as amedian lobe. The treatment device facilitates the delivery of assembliesaccomplishing destruction or alteration of tissue.

The treatment apparatus of the present disclosure includes varioussubassemblies which are mobilized via an actuator or other manuallyaccessible structure. The operation of the subassemblies is coordinatedand synchronized to ensure accurate and precise delivery.

In one particular aspect, the present invention is directed towards atreatment device which accomplishes the delivery of structures thataccomplish the destruction or alteration of prostatic tissue. Theprocedure can be viewed employing a scope inserted in the device. Also,the delivery device can be sized and shaped to be compatible inside asheath up to 24F, preferably a 19F sheath or smaller.

Various alternative methods of use are contemplated. The disclosedapparatus can be used to improve flow of a body fluid through a bodylumen, modify the size or shape of a body lumen or cavity, treatprostate enlargement, or treat urinary incontinence, and/or treatvarious other disorders where a natural or pathologic tissue or organ ispressing on or interfering with an adjacent anatomical structure.

In a specific application, the disclosed apparatus are contemplated tobe employed to destruct or alter an enlarged median lobe of a prostate.In one aspect, a treatment device is inserted into a prosthetic urethratransurethrally and the device is employed to destroy or alter themedian lobe. Further, the system can additionally include an ultrasoundor other imaging probe.

In another aspect, the delivery device housing the assembly is firstguided into an ejaculatory duct of a patient. The assembly is thendeployed from the ejaculatory duct to treat the median lobe so that itcan be destroyed or altered. In yet a further aspect, an anteriorapproach can be taken such that tissue on an opposite side of theurethra to that of the median lobe is treated to open the urethra.

Various structures can be employed to engage and capture prostaticmedian lobe tissue. Moreover, various energies such as microwave or RFenergy can be employed to destroy tissue along with or independent ofcapturing tissue with other devices. In particular, rotatable orexpandable blades, articulating cutters, and pinchers can be configuredto engage and capture tissue. Further, blunt dissectors with or withoutblades can be utilized for accessing tissue and performing othertreatments.

Other features and advantages of the present invention will becomeapparent from the following detailed description, taken in conjunctionwith the accompanying drawings, which illustrate, by way of example, theprinciples of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a cross-sectional view, depicting anatomy surrounding aprostate in a human subject;

FIG. 2 is an enlarged cross-sectional view, depicting anatomysurrounding a prostate;

FIG. 3 is a schematic view, depicting prostatic anatomy zones;

FIG. 4 is a schematic cross-sectional view, depicting further details ofthe anatomy zones shown in FIG. 3;

FIG. 5 is a cross-sectional view, depicting a normal prostate;

FIG. 6 is a cross-sectional view, depicting a prostate with enlargedlateral lobes;

FIG. 7 is a cross-sectional view, depicting a prostate with enlargedlateral lobes and an enlarged median lobe;

FIGS. 8A-C are side and perspective views, depicting one embodiment of adelivery device and various features thereof;

FIGS. 9A-C are side and cross-sectional views, depicting anotherembodiment of a delivery device;

FIGS. 10A-B are cross-sectional views, depicting anatomy inflicted withan enlarged median lobe;

FIG. 11 is a cross-sectional view, depicting accessing a median lobefrom a urethra;

FIG. 12 is a cross-sectional view, depicting accessing a median lobefrom an ejaculatory duct;

FIG. 13 is a side view, depicting suction for capturing material;

FIG. 14 is a side view, depicting a rotating blade for capturingmaterial;

FIG. 15 is a partial cross-sectional view, depicting a curved blade forcapturing material;

FIG. 16 is a partial cross-sectional view, depicting a tissue engagingstructure including articulating arms;

FIGS. 17A-B are side views, depicting an expandable blade device;

FIGS. 18A-B are side views, depicting blunt dissector devices;

FIGS. 19A-B are side views, depicting dissectors including cuttingblades;

FIG. 20 is a partial cross-sectional view, depicting a noose device;

FIG. 21 is a partial cross-sectional view, depicting applying microwaveenergy to a median lobe;

FIG. 22 is a partial cross-sectional view, depicting a pinching device;

FIGS. 23A-B are partial cross-sectional views, depicting cutting andstapling prostatic tissue; and

FIGS. 24A-B are partial cross-sectional views, depicting cutting tissueadjacent a bladder neck.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Turning now to the figures, which are provided by way of example and notlimitation, the present disclosure is directed to a device configured todeliver an anchor assembly within a patient's body for treatmentpurposes. The disclosed apparatus can be employed for various medicalpurposes including but not limited to destructing or altering tissues,organs, anatomical structures, grafts or other material found within apatient's body. Such approaches are intended to facilitate the treatmentof diseases or disorders such as the displacement, compression and/orretraction of the median lobe of a prostate.

With reference to FIGS. 1-4, various features of urological anatomy of ahuman subject are presented. The prostate gland PG is a walnut-sizedmuscular gland located adjacent the urinary bladder UB. The urethra UTruns through the prostate gland PG. The prostate gland PG secretes fluidthat protects and nourishes sperm. The prostate also contracts duringejaculation of sperm to expel semen and to provide a valve to keep urineout of the semen. A capsule C surrounds the prostate gland PG.

The urinary bladder UB holds urine. The vas deferentia VD define ductsthrough which semen is carried and the seminal vesicles SV secreteseminal fluid. The rectum R is the end segment of the large intestineand through which waste is dispelled. The urethra UT carries both urineand semen out of the body. Thus, the urethra is connected to the urinarybladder UB and provides a passageway to the vas deferentia VD andseminal vesicles SV.

Further, the trigone T (See FIG. 3) is a smooth triangular region of thebladder. It is sensitive to expansion and signals the brain when theurinary bladder UB is full. The verumontanum VM is a crest in the wallof the urethra UT where the seminal ducts enter. The prostatic urethrais the section of the urethra UT which extends through the prostate.

The prostate gland can be classified by zones or described by referringto its lobes (See FIG. 4). Whereas the zone classification is typicallyused in pathology, the lobe classification is more often used inanatomy. The central zone (a) of a prostate gland PG is about 25% of anormal prostate and this zone surrounds the ejaculating ducts. There issome prevalence of benign prostate hyperplasia in the transition zone.The fibromuscular zone (b) is usually devoid of glandular components andas its name suggests, is composed of only muscle and fibrous tissue. Thetransitional zone (c) generally overlays the proximal urethra and is theregion of the gland that grows throughout life. Also, this lobe is oftenassociated with the condition of benign prostatic enlargement. Finally,the peripheral zone (d) is the sub-capsular portion of the posterioraspect of the prostate gland that surrounds the distal urethra.

The lobe characterization is different from the zone characterization,but there is some overlap. The anterior lobe is devoid of glandulartissue and is completely formed of fibromuscular tissue. This lobe thusroughly corresponds to the anterior portion of the transitional zone(c). The posterior lobe roughly corresponds to the peripheral zone (d)and can be palpated through the rectum during a digital rectal exam. Theposterior lobe is the site of 70-80% of prostatic cancers. The laterallobe is the main mass of the prostate and is separated by the urethra.It has been described as spanning all zones. Lastly, the median loberoughly corresponds to part of the central zone. It varies greatly insize and in some cases is devoid of glandular tissue.

A large or enlarged median lobe can act as a ball valve, blocking thebladder neck. Various approaches are contemplated to address such acondition. Thus, it is contemplated that the median lobe can becompressed, displaced and/or retracted to eliminate or decrease theblocking of the bladder neck.

Turning now to FIGS. 5-7, there are shown various prostate glands incross-section. FIG. 5 depicts the urinary bladder UB and prostate glandPG of a healthy subject. FIG. 6 illustrates an individual with aprostate having enlarged lateral lobes LL and FIG. 7 depicts a subjectsuffering from both enlarged lateral lobes LL and an enlarged medianlobe ML. It is to be appreciated that such enlarged anatomy impinges onthe urethra UT and affects normal functioning. The following devices andapproaches are intended to be employed to free up a path through theprostatic urethra.

Referring now to FIGS. 8A-C, there is shown one embodiment of atreatment device 100. This device is configured to include structurethat is capable of both gaining access to an interventional site as wellas advancing structure into the prostate to accomplish the desireddestruction of prostatic tissue. The device is further contemplated tobe compatible for use with a 19F sheath. The device additionallyincludes structure configured to receive a remote viewing device (e.g.,an endoscope) so that the steps being performed at the interventionalsite can be observed.

Prior to use of the present device 100, a patient typically undergoes afive day regiment of antibiotics. A local anesthesia can be employed forthe interventional procedure. A combination of an oral analgesic with asedative or hypnotic component can be ingested by the patient. Moreover,topical anesthesia such as lidocaine liquids or gel can be applied tothe bladder and urethra.

The treatment device 100 includes a handle assembly 102 connected to anelongate tissue access assembly 104. The elongate tissue access assembly104 houses components employed to destruct or alter a prostatic lobe andis sized to fit into a 19F cystosopic sheath for patient toleranceduring a procedure in which the patient is awake rather than undergeneral anesthesia. The tissue access assembly is stiff to allow manualcompression of tissue at an interventional site by leveraging or pushingthe handle assembly 102.

The treatment device 100 further includes a number of subassemblies. Ahandle case assembly 106 including mating handle parts which form partof the handle assembly 102. The handle assembly 102 is sized and shapedto fit comfortably within an operator's hand and can be formed fromconventional materials. Windows can be formed in the handle caseassembly 106 to provide access to internal mechanisms of the device sothat a manual override is available to the operator in the event theinterventional procedure needs to be abandoned.

In one embodiment, the treatment device 100 is equipped with variousactivatable members which facilitate delivery of tissue destruction oraltering structure. A needle actuator 108 is provided and as describedin detail below, effectuates the advancement of a needle assembly to aninterventional site. In a preferred embodiment, the needle assembly hasa needle that moves through a curved trajectory and exits the needlehousing in alignment with a handle element, and in particularembodiments, in alignment with the grip. In various other embodiments,the needle housing is oriented such that the needle exits the housing ateither the two o'clock or ten o'clock positions relative to a handlegrip that is vertical. A needle retraction lever assembly 110 is alsoprovided and when actuated causes the needle assembly to be withdrawnand expose tissue treatment structure. This action and the structureinvolved is also described in detail below.

In one particular, non-limiting use in treating a prostate, the elongatetissue access portion 104 of a treatment device is placed within aurethra (UT) leading to a urinary bladder (UB) of a patient. In oneapproach, the delivery device can be placed within an introducer sheath(not shown) previously positioned in the urethra or alternatively, thedelivery device can be inserted directly within the urethra. The patientis positioned in lithotomy. The elongate portion 104 is advanced withinthe patient until a leading end thereof reaches a prostate gland (PG).In a specific approach, the side(s) (i.e., lobe(s)) of the prostate tobe treated is chosen while the device extends through the bladder andthe device is turned accordingly. The distal end of the elongate portioncan be used to depress the urethra into the prostate gland bycompressing the inner prostate tissue. The inside of the prostate gland(i.e., adenoma) is spongy and compressible and the outer surface (i.e.,capsule) of the prostate gland is firm. By the physician viewing with anendoscope, he/she can depress the urethra into the prostate glandcompressing the adenoma and creating the desired opening through theurethra. To accomplish this, the physician rotates the tool. Thephysician then pivots the tool laterally about the pubic symphysis PSrelative to the patient's midline.

As shown in FIGS. 8A-B, the treatment device is at this stage configuredin a ready state. The needle actuator 108 and the needle retractinglever 110 are in an inactivated position.

Upon depression of the needle actuator 108, the needle assembly 230 isadvanced from within the elongate member 104 (See FIG. 8C). The needlecan be configured so that it curves back toward the handle as it isejected. In use in a prostate intervention, the needle assembly isadvanced through and beyond a prostate gland (PG). Spring deploymenthelps to ensure the needle passes swiftly through the tough outercapsule of the prostate without “tenting” the capsule or failing topierce the capsule. In one approach, the needle is made from Nitinoltubing and can be coated with Parylene N. Such a coating helpscompensate for frictional or environmental losses (i.e. wetness) whichmay degrade effectiveness of needle penetration.

After complete depression of the needle actuator 108 and the unlockingof the needle retraction lever 110, the needle retraction lever 110 canbe actuated. Such action results in a withdrawal of the needle assembly230. In one embodiment, the needle 230 is withdrawn further than itsoriginal position within the device pre-deployment.

As an alternative, the treatment device can be defined by an elongatecatheter 300. A distal end of the catheter 300 can include two openings,one opening 302 for a working device and a second opening 304 for visionand light. A proximal end 306 of the catheter can be adapted to connectto one or more of a light source and a camera. Extending along a lengthof the catheter 300 (See FIG. 9B) can be three or more lumens. There canbe a first working lumen 310 in communication with the working deviceopening 302 and a working device channel 311. A second lumen 312 can besized and shaped to receive camera optics (fibers) and light sourcefibers connected to the proximal end 306 and can extend to the seconddistal opening 304. Finally, a third lumen 314 can be provided to extendfrom a irrigation part 315 to a point near the distal end of the device(not shown). In another embodiment, the working device opening 302 canbe moved proximally (See FIG. 9C) so that a working device such as aneedle 230 can be extended from a side of the treatment device 300, andperhaps more directly into target tissue.

Turning now to FIGS. 10A-B, an approach to treating patients with medianlobe ML disease is presented. Such an approach can be used as acomplementary therapy with separate treatments for lateral lobes or canbe employed to solely treat a median lobe ML. Because an enlarged medianlobe ML can extend into the urinary bladder UB and may act as a ballvalve interfering with normal function (See FIGS. 10A and 10B; FIG. 10Bis a view through the prostatic urethra and into the urinary bladder),special consideration to moving tissue away from a ball valve locationmay facilitate accomplishing optimal results. The purpose here being toprovide a less invasive means to treat median lobe hypertrophy ascompared to TURP and TUIP (transurethral incision of the prostate). Byavoiding such invasive approaches, there is minimal risk of disruptingthe smooth muscle of the bladder neck and nerve tissue, ejaculatingfunction and continence complications will likely be lower. BPH is avery prevalent disease that dramatically affects the quality of life ofolder men. About 30% of these men have a median lobe that creates aball-valve effect. The presently disclosed procedure can significantlyimprove the urinary symptoms of these patients with a much better sideeffect profile. However, certain previously contemplated procedurescurrently require patient screening in order to exclude some patientswith median lobes requiring treatment because these patients do notrespond as readily to the therapy. Because current medical therapy maynot be effective on median lobes, these patients only haveresection/ablation as available options which both carry significantside effects. Thus, there exists a need to treat patients with medianlobes without the significant side effect profile due to resection orablation.

As an initial step, sagittal views of a patient's bladder and prostatecan be taken using transabdominal or transrectal ultrasonography. Inthis way, the patient's anatomy can be assessed. In this regard, anintravesical prostate measurement is taken to determine the verticaldistance from a tip of the median lobe protrusion to the base of thebladder. After assessing the anatomy, the elongate tissue accessassembly of a treatment device (See FIGS. 8-9C) can be advanced withinthe urethra UT (See FIG. 11). Various approaches to altering theprostate gland can then be undertaken.

While current treatments may be focused on lateral lobes of theprostate, patients with median lobe disease might get improved outcomeswith a complementary therapy designed specifically for the median lobe.Because the median lobe may extend into the bladder and may act as aball valve, special consideration to creating a channel via a tunnel maybe advantageous for optimal results. In one approach, it is contemplatedthat a passageway through the median lobe can be created to allow urineto pass. A tunnel through the prostate median lobe can be produced bycreating a passageway through the median lobe which allows urine to passfrom the bladder into the urethra. In this concept, the passageway canbe created by either removing tissue or displacing tissue. Specifically,removing tissue to produce the tunnel could be done using any of theablation techniques available (e.g. RF Energy, Lasers, etc.). Withregard to displacing tissue, an implant in the form of a suture or acylindrical shaped tunnel or mesh may be implanted in the median lobe.

Thus, in this way, a passageway for urine to flow is provided even whenthe median lobe acts as a ball valve and “closes” on the bladder neck.Moreover, due to a transurethral delivery approach, minimal tissue iseither being removed or displaced to create this passageway. This leadsto minimal patient discomfort, scarring, and general complications. Thisconcept is less invasive than current minimally invasive therapies(TUMT, TUNA, TUIP and TURP). Accordingly, by reducing the amount oftissue removed there is minimal risk of disrupting the smooth muscle ofthe bladder neck and nerve tissue, ejaculatory function and continencecomplications will likely be lower than these other noted therapies.

After accessing the prostate using the treatment device described above,the median lobe can be injected with a pharmacological agent or drug,such as the Botulinum Toxin. The drug mechanisms could includerelaxation of the smooth muscle tissue such that the median lobe wouldnot retain its shape and seal to the bladder neck and local apoptosis ofmedian lobe cells can ensue. Apoptosis could result in shrinkage of themedian lobe or change in shape of the median lobe such that obstructionof the bladder neck opening is reduced. Small needles and relatively fewinjections sites could be employed as ways to reduce pain to thepatient. The injections could also be potentially administered usingflexible cystoscopy, so that damage to the urethra is minimal. Thisapproach involves fast treatment times, a low level of pain for thepatient if small needles are suitable, and the use ofminimally-invasive, flexible cystoscopy. As an alternative, drugs can beinjected in the area around the median lobe. Pharmacological agentscould also be administered to the median lobe through the perineum orrectum.

In yet another approach, the catheter or treatment device is insertedinto the urethra and guided into the ejaculatory duct ED (See FIG. 12).A needle 230 is advanced into the enlarged median lobe ML. The needle230 can be used to remove tissue from the median lobe via a vacuum (SeeFIG. 13) from within the median lobe. The volume of the enlarged medianlobe is reduced, lowering the obstruction of the bladder neck andurethra UT. As the trans-ejaculatory duct ED delivery scheme and needlestick are minimally invasive urethral tissue is preserved. Further,there may be no need for implant materials. It is to be recognized thata vacuum can be used to remove tissue once the median lobe is accessedfrom other routes as well.

The contemplated approaches could be used in conjunction with a primarydevice or catheter in the urethra/bladder neck and a secondary catheteror device in the ejaculatory duct to treat the median lobe. The idea ofapproaching the median lobe from the anterior and posterior sides mayincrease an ability to locate and treat it. The median lobe could betreated with smaller devices from both the bladder side and theejaculatory duct side, via multiple smaller vacuum needles, cryoablationtreatments, or heating treatments (radiofrequency, microwave, laser,etc). The catheter or device may be flexible, rigid or semi-rigid. Theneedle may exit at the tip of the device, or may exit at the side of thedevice. Some portion or the entire catheter or device may havearticulation control to allow for navigating and positioning.

In one specific application, the treatment catheter may be employed tofreeze tissue via direct injection of a freezing agent, like liquidnitrogen, into the tissue. The freezing may be achieved via thermalconduction through the needle. The needle 230 may be a material withhigh thermal conductivity. The inner diameter ID of the needle maycontain a cryogenic agent, liquid nitrogen, rapidly expanding gas, orother. The needle may further contain a temperature probe (not shown) toallow a feedback loop to a control system to control the size and volumeof tissue to be frozen. The needle may exit the distal end of thecatheter, or may exit the side of the treatment catheter. The cathetermay be flexible, rigid or semi-rigid. Again, some portion or the entirecatheter may have articulation control to allow for navigating andpositioning.

In another specific example (See FIG. 14), the catheter may contain arotating helical blade 550 which is advanced out of a working channel orneedle 230, and cuts tissue, assisting in tissue removal with or withouta vacuum assistance. Again, the catheter may be flexible, rigid orsemi-rigid. The working channel may exit at the tip of the device, ormay exit at the side of the device. Some portion or the entire catheteralso may have articulation control to allow for navigating andpositioning. Additionally, an RF generator can be included forcauterization after tissue removal.

Such a device could be stand-alone, i.e. not requiring a TRUS probe. Thedevice could accommodate insertion of an ultrasound or other imagingprobe into the device for guidance and could have an integrateddisposable imaging system. A handle on the needle device can be added tofully or partially automate delivery. The handle can have user settingsfor needle depth. The needle depth can be fixed in the manufacturingfactory and available in different lengths to the market. The user canthen select the appropriate length based on TRUS or other imaging data.Also, the needle can be coated or doped with antimicrobial materialssuch as silver. A Foley catheter or other device could be used to locatethe urethra on the TRUS image. In fact, a customized Foley cathetercould provide a specific deployment target and a Doppler flow feature onthe ultrasound could be sued in conjunction with a Foley catheter tofurther enhance the target.

Turning now to FIGS. 15-19B, various other structure are presented forremoving tissue from a lobe of a prostate. As shown in FIG. 15, thetissue altering or removing structure can be embodied in a linearlyactivated blade 560. The blade 560 can have a curved distal end, with ahollowed out receptacle that facilitates scooping of tissue. The tissueremoving structure can also be embodied in a grasper assembly 570 (FIG.16). The grasper assembly 570 can include articulating arms 572 withinwardly directed blade tips 574. Both structures are sized and shapedto be advanceable through the treatment device, and can in particular,be extendable from and through a needle 230. As shown in FIGS. 17A-B,tissue removing structures can also be defined by an elongate memberwith a distal end defined by an expandable cutting member 580.

With reference to FIGS. 18A-B, the treatment device can further includean extending blunt dissecting tip 590. A penetrating tip is extended aspecified amount to penetrate the tissues near the device (e.g. urethra,prostate tissue and capsule) and the blunt dissector 590 is used toextend the access in an atraumatic way along the tissue planes that werefirst accessed using the penetrating tip. The needle or penetrating tipmay be extended to a pre-determined distance or using a pre-determinedforce in order to sufficiently penetrate the desired tissues. It couldbe advanced via hand, spring, electrical, or pneumatic power and couldbe controlled via electrical or other feedback from the tissue near thedistal tip of the penetrating tip. The blunt dissector 590 may be oftuned flexibility with a flexible tip that can buckle over to provide alarge atraumatic radius for tissue dissection. Either or both parts ofthe device could be fabricated of implant-grade materials and could beseparated from the treatment device. One means for this is a wire-likedevice that is inserted and buckles and fold upon resistance such thatit forms a knob or nest which is larger than the access hole andtherefore resists pullout through the access hole. An electrical systemcould be added to the system such that penetration of a nearby organ(e.g. bladder or rectum) could be detected by the completion of anelectrical circuit. In this regard, a conductive strip 592 can be addedto the blunt tip dissector 590.

A dissector 600 can further or alternatively include an integral blade602 positioned proximal a terminal end of the device as well as anarticulating head 604 (FIG. 19A). Cutting action is provided by pivotingthe articulation head. In place of the integral blade, the dissector canfurther include a retractable blade 606 (FIG. 19B) which can betranslated to effect desired cutting action.

Still yet other approaches to remove median lobe tissue or reduce themedian lobe volume are shown in FIGS. 20-23B. As shown in FIG. 20, atransurethral treatment device 300 can be used to apply a noose orligature clip 610 around the median lobe ML. The noose or ligature clip620 is left in place long enough to cause tissue necrosis. Once themedian lobe separates from the patient, it would be either voided aftercatheter removal or removed during a second procedure. This approachinvolves no tissue cutting and could have minimal blood loss compared toconventional BPH surgical approaches. Important urological anatomy isundisturbed and erectile dysfunction and incontinence would potentiallybe lower than other BPH therapies.

A transurethral treatment device can also be employed to apply microwaveenergy 620 to the median lobe ML to cause tissue necrosis (See FIG. 21).Over time, the dead median lobe tissue would contract and allow improvedurological function. Current TUMT technology and treatment techniquescan thus be leveraged by applying microwave energy to the median lobe tokill and shrink the tissue to alleviate BPH symptoms. This wouldspecifically target the median lobe and could prove to be a faster andless expensive procedure than current TUMT treatment modalities and beless traumatic to the patient.

A transurethral treatment catheter 300 including a translatable pincher620 that pinches the median lobe ML to eliminate its blood supply. Thecatheter 300 is left in place long enough to cause tissue necrosis. Oncethe median lobe separates from the patient, it would be either voidedafter catheter removal or removed during a second procedure. As with thenoose/ligature clip approach, this approach involves no tissue cuttingand could have minimal blood loss compared to current BPH surgicalapproaches. Important urological anatomy is again undisturbed anderectile dysfunction and incontinence would potentially be lower thanother BPH therapies.

Alternatively referring to FIGS. 22-23B, a transurethral treatmentdevice 300 for removing median lobe ML tissue can include a cuttingwire, ring or blade 640. The cutting wire, ring or blade 640 could havethe means to electro-cauterize the tissue cut plane to minimize bloodloss. The median lobe ML tissue could then be morsellized using asecondary device. As such, current electro-cauterizing tissue cuttingtechnology to effectively remove the median lobe. Specially targetingthe median lobe ML could prove to be a faster and less expensiveprocedure than current BPH treatment methods and be less traumatic tothe patient. Structure can also be provided to simultaneously staple 650and cut the enlarged median lobe ML. The severed median lobe tissuecould be morsellized using a secondary device.

Finally, with reference to FIGS. 24A-B, rather than cut through theurethra UT and create an open wound exposed to urine, access to thebladder neck BN can be gained via a small puncture. Such a smallpuncture can be formed by a needle 660 and the same can be used totunnel sub-epithelially to the bladder neck BN. Circular muscle of thebladder neck BN can then be cut to release the bladder neck BN. Thebladder neck opening will thus relax and the obstructing median lobe MLor bladder neck adenoma will recede into newly released space away fromthe urethra UT. Such action reduces the valve pressure of the bladderneck obstruction.

It is to be recognized that the devices and methods disclosed herein canbe used to treat a variety of pathologies in a variety of lumens ororgans comprising a cavity or a wall. Examples of such lumens or organsinclude, but are not limited to urethra, bowel, stomach, esophagus,trachea, bronchii, bronchial passageways, veins (e.g. for treatingvaricose veins or valvular insufficiency), arteries, lymphatic vessels,ureters, bladder, cardiac atria or ventricles, uterus, fallopian tubes,etc.

Moreover, it is to be appreciated that the disclosure has been describedhereabove with reference to certain examples or embodiments of theinvention but that various additions, deletions, alterations andmodifications may be made to those examples and embodiments withoutdeparting from the intended spirit and scope of the invention. Forexample, any element or attribute of one embodiment or example may beincorporated into or used with another embodiment or example, unless todo so would render the embodiment or example unpatentable or unsuitablefor its intended use. Also, for example, where the steps of a method aredescribed or listed in a particular order, the order of such steps maybe changed unless to do so would render the method unpatentable orunsuitable for its intended use. All reasonable additions, deletions,modifications and alterations are to be considered equivalents of thedescribed examples and embodiments and are to be included within thescope of the following claims.

Thus, it will be apparent from the foregoing that, while particularforms of the invention have been illustrated and described, variousmodifications can be made without parting from the spirit and scope ofthe invention.

1. A method for treating benign prostatic hypertrophy, comprising: assessing an anatomy of a median lobe; inserting a treatment device within a urethra, the treatment device includes an extendable needle and an elongate member; actuating the treatment device to advance the needle within the median lobe; and manipulate the elongate member to capture, separate, cut, dissect and/or remove tissue of the median lobe.
 2. The method of claim 1, wherein the elongate member is advanceable through the needle.
 3. The method of claim 2, further comprising advancing the elongate member through and beyond the needle.
 4. The method of claim 1, further comprising advancing the treatment device into an ejaculatory duct.
 5. The method of claim 1, further comprising applying energy to the median lobe to destroy tissue.
 6. The method of claim 5, wherein the energy is microwave energy.
 7. The method of claim 1, further comprising cauterizing median lobe tissue.
 8. The method of claim 1, further comprising applying a vacuum to remove tissue from the median lobe.
 9. The method of claim 1, wherein the elongate member includes a rotatable helical blade, further comprising rotation of the helical blade.
 10. The method of claim 1, wherein the elongate member includes a curved cutting blade and further comprising manipulating the curved blade to cut median lobe tissue.
 11. The method of claim 1, wherein the elongate member includes articulating cutting arms and further comprising articulating the arms to cut median lobe tissue.
 12. The method of claim 1, wherein the elongate member includes an expandable cutter and further comprising expanding the cutter to cut median lobe tissue.
 13. The method of claim 1, wherein the elongate member is a blunt dissector and further comprising dissecting median lobe tissue with the dissector.
 14. The method of claim 13, wherein the blunt dissector further includes a cutter blade.
 15. The method of claim 1, wherein the elongate member includes a ligature and further comprising configuring the ligature about the median lobe.
 16. A method for treating benign prostatic hypertrophy, comprising: assessing an anatomy of a median lobe; inserting a treatment device within a urethra; actuating the treatment device to advance a cutting device within a bladder neck; and cutting bladder neck and/or soft tissues surrounding the bladder neck.
 17. The method of claim 16, further comprising relaxing an opening of the bladder neck so that space is created to permit an increased luminal opening at the bladder neck.
 18. A system for enlarged median lobe treatment, comprising: a treatment device, the device including an extendable needle; and an elongate member, the elongate member sized and shaped to be advanced within and beyond the needle and including structure for capturing and/or removing median lobe tissue.
 19. The system of claim 18, the system further comprising means for applying energy to destroy or cauterize median lobe tissue.
 20. The system of claim 18, the elongate member including one or more of a vacuum, a cutter, a pincher, a ligature, or a dissector. 